What are the changes?
The HHS press release encompasses the most significant changes adopted in the final rule. The federal register includes an executive summary outlining the changes as well as the final regulatory text.
Final rule changes include:
- Improving the informed consent document and process to increase subject understanding
- Requiring that consent forms for certain federally funded clinical trials be posted on a public website
- Requiring single Institutional Review Board (sIRB) review for cooperative research for some studies
- Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens
- Eliminating continuing review for certain minimal risk research
- Establishing new exempt categories of research based on level of risk posed to subjects
- Adopting the definition of “Clinical Trial” that includes behavioral health-related outcomes
The effective date is on 19 January 2018 for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements will be effective on 20 January 2020.
CITI Program's Plan
CITI Program will be addressing the changes in several ways including updating content to reflect the new requirements. As always, we will keep organizations abreast of our actions through email and web announcements.
Our colleague Gary Chadwick, Senior Consultant at HRP Consulting Group, has summarized the changes which can be found on the HRP Consulting Group Website “New Final Common Rule - Summary of Changes.”
- Federal Register: Federal Policy for the Protection of Human Subjects (01/19/2017)
- HHS Press Release About the Final Rule
- HRP Consulting Group "New Final Common Rule - Summary of Changes."
- PRIM&R's Revised Common Rule Information